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Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)

Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06350656
Acronym
EC2
Enrollment
30
Registered
2024-04-05
Start date
2023-03-31
Completion date
2024-04-30
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrospinal; Disorder

Keywords

Cerebrospinal compliance, Intracranial pressure., Head injury, Pulse waveform

Brief summary

Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy. In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.

Detailed description

This study aims to analyse the shape of the different components of the intracranial pressure waves (P1, P2, and P3) when the patient is flattened to determine an index to define the level of cerebral compliance.

Interventions

Post-retrieval from the medical record

OTHERTherapeutic data collection

Post-retrieval from the medical record

OTHERIntraCranial Pression (ICP) values collection

Post-retrieval of ICP values from the monitor

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Continuous intracranial pressure monitoring * Sedated patient on mechanical ventilation

Exclusion criteria

* Craniectomy * Major hemodynamic failure

Design outcomes

Primary

MeasureTime frameDescription
Intracranial pressure (mmHg)Year : 1Intracranial pressure is measured before (Raising the head by 30°) and during the flattening (Raising the head by 0°). Theses measures are done twice a day. The mean of theses values is calculated.

Secondary

MeasureTime frameDescription
Correlation between ICP (Intra Cranial Pressure) doses and cerebral complianceYear : 1Compare the ICP (Intra Cranial Pressure) dose value with the compliance index during the period before or after the flattening

Countries

France

Contacts

Primary ContactLAURENT GERGELE, MD
laurent.gergele@chu-st-etienne.fr(0)477828593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026